Expected changes in the innovation funding (NUB) procedure in Germany

On July 30, 2026, the Statutory Health Insurance Contribution Rate Stabilization Act (GKV-Beitragssatzstabilisierungsgesetz) entered into force, introducing important changes to the assessment of new examination and treatment methods associated with NUB applications under §137h SGB V.

The legislation substantially expands the scope of the §137h assessment procedure. In the future, it will no longer be limited to methods whose technical application is substantially based on the use of a high-risk medical device. Instead, the procedure will generally be triggered by the first NUB application for a new examination or treatment method, provided that the method is not based primarily and exclusively on the administration of a medicinal product.

Where the technical application of the method is substantially based on the use of a medical device, the hospital must continue to submit the required information in agreement with the manufacturer. This information must include, in particular, evidence on the clinical benefit of the device and complete data from clinical studies conducted with it. 

The requirement for a new theoretical-scientific concept remains in force. A Federal Joint Committee (G-BA) assessment will be conducted only if the method is based on a new concept. Before initiating the assessment, the G-BA must, within two weeks of receiving the submitted information, publicly invite other hospitals planning to use the method and other affected medical device manufacturers to provide additional information, generally within one month.

Although the Act entered into force on July 30, 2026, the revised submission requirements under §137h will not apply immediately. The G-BA must first amend its Rules of Procedure to implement the new process. The Act requires the relevant procedural provisions to be adopted by October 31, 2026. The revised requirements will become applicable only once the amended G-BA Rules of Procedure enter into force.

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